Impact of Aripiprazole Once Monthly Medications on Changes in Brain Structure and Metabolism

NCT02237417 | Completed Phase 4 Results DMC

• 1 other identifier: IRB_00073657
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 4, randomized, open-label, parallel group study designed to assess the clinical and biological effects of 12 months of treatment with long acting intramuscular (IM) aripiprazole (Abilify®) as measured by clinical and behavioral measures, and changes on magnetic resonance imaging (MRI) scans in subjects with schizophrenia compared with SOC oral antipsychotic medications and compared with a healthy control group.

Conditions

Schizophrenia

Keywords

MRI; Imaging; Antipsychotic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Changes in Fractional Anisotropy (FA)

  To determine if there are differences in prefrontal white matter fractional anisotropy (FA) in subjects with schizophrenia from baseline at 12 months of treatment with aripiprazole (Abilify®) once monthly compared with standard of care (SOC) oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI (Geodon®)).

  12 months

Study Arms (3)

Healthy Control

OTHER

Healthy individuals with no mental health diagnosis

Other: No Treatment

Individuals with Schizophrenia (Group A)

ACTIVE COMPARATOR

Individuals with a diagnosis of Schizophrenia undergoing standard of care treatments.

Drug: Standard of Care Oral antipsychotics

Individuals with Schizophrenia (Group B)

ACTIVE COMPARATOR

Individuals with Schizophrenia who are receiving treatment with Aripiprazole once monthly injections.

Drug: IM aripiprazole once monthly

Interventions

Standard of Care Oral antipsychotics DRUG

A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.

Individuals with Schizophrenia (Group A)

IM aripiprazole once monthly DRUG

A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.

Individuals with Schizophrenia (Group B)

No Treatment OTHER

A total of 15 healthy controls will participate in the study and will not receive medication

Healthy Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are able to provide written informed consent.
• Are male and female subjects 18 to 35 years of age, inclusive, at time of informed consent.
• Have a current diagnosis of schizophrenia as defined by DSM IV-TR criteria and a history of the illness for at least 1 year prior to screening and at least two prior psychotic episodes based on medical records or a qualified and reliable health care provider.
• Require, in the investigator's judgment, chronic treatment with an antipsychotic medication.
• Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, and discontinuation of prohibited concomitant medications, read and understand the written word in order to complete subject-reported outcomes measures, and be reliably rated on assessment scales.
• Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to practice double barrier forms of birth control from trial screening through 30 days (for females) and 90 days (for males) from the last dose of IMP for SOC oral antipsychotics and 150 days for females and 180 days for males for aripiprazole depot. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control depot injections, condom, or sponge with spermicide.

You may not qualify if:

• Presence of any metal implants, pacemakers, unremovable prosthetic device, or other device or situation that may preclude imaging
• History of a head injury with loss of consciousness \> 5 minutes
• Has a significant medical condition that would expose the subject to undue risk or interfere with study assessments.
• Has a current DSM-IV-TR diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Is considered resistant/refractory to antipsychotic treatment by history (failed two prior antipsychotic medication trials) or response only to clozapine.
• Has a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's discretion.
• Has met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening, excluding caffeine, nicotine, or marijuana.
• Is known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to antipsychotic agents, including aripiprazole.
• Has a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening per the investigator's discretion.
• Has a history of seizures or any other medical condition that would expose the subject to undue risk or interfere with study assessments.
• Is involuntarily incarcerated.
• Has undergone electroconvulsive therapy in the 2 years prior to enrollment in the study.
• Has used an investigational agent or has participated in a clinical study with aripiprazole IM depot or any other antipsychotic depot preparation within 30 days of screening.
• Has clinically significant abnormalities in laboratory test results, vital signs, or ECG results.
• Requires more than one benzodiazepine beyond screening (e.g., lorazepam and oxazepam).

Sponsors & Collaborators

• University of Utah: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Wilt, Timothy
• Organization: Otsuka

timothy.wilt@otsuka-us.com

240.683.3095

Study Officials

• Deborah Yurgelun-Todd, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 11, 2014
• Study Start: September 1, 2014
• Primary Completion: November 30, 2018
• Study Completion: July 30, 2020
• Last Updated: March 14, 2025
• Results First Posted: February 15, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)